Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medsphere International, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041980 | MSI S-500L RF GENERATOR | Medsphere International, Inc. | 2004-08-06 | 14 | 0 |
| K033888 | MSI MODEL S-500 RF GENERATOR | Medsphere International, Inc. | 2004-04-02 | 108 | 0 |
| K030996 | MSI SA ELECTRODES | Medsphere International, Inc. | 2003-05-30 | 60 | 0 |
| K024266 | MSI TA ELECTRODES | Medsphere International, Inc. | 2003-03-12 | 79 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda